"Two per cent isn't a lot, but when it comes to death it seems quite a lot anyway": patients' perception of risk and willingness to accept risks associated with thrombolytic drug treatment for acute stroke.

BACKGROUND: Thrombolytic drugs to treat an acute ischaemic stroke reduce the risk of death or major disability. The treatment is, however, also associated with an increased risk of potentially fatal intracranial bleeding. This confronts the patient with the dilemma of whether or not to take a risk of a serious side effect in order to increase the likelihood of a favourable outcome. OBJECTIVE: To explore acute stroke patients' perception of risk and willingness to accept risks associated with thrombolytic drug treatment. DESIGN: Eleven patients who had been informed about thrombolytic drug treatment and had been through the process of deciding whether or not to participate in a thrombolytic drug trial went through repeated qualitative, semistructured interviews. RESULTS: Many patients showed a limited perception of the risks connected with thrombolytic drug treatment. Some perceived the risk as not relevant to them and were reluctant to accept that treatment could cause harm. Others seemed to be aware that treatment would mean exposure to risk. The patients' willingness to take a risk also varied substantially. Several statements revealed ambiguity and confusion about being involved in a decision about treatment. The patients' reasoning about risk was put into the context of their health-related experiences and life histories. Several patients wanted the doctor to be responsible for the decisions. CONCLUSION: Acute stroke patients' difficulties in perceiving and processing information about risk may reduce their ability to be involved in clinical decisions where risks are involved.

I don't like that, it's tricking people too much...: acute informed consent to participation in a trial of thrombolysis for stroke.

BACKGROUND: Informed consent is regarded as a contract between autonomous and equal parties and requires the elements of information disclosure, understanding, voluntariness and consent. The validity of informed consent for critically ill patients has been questioned. Little is known about how these patients experience the process of consent. OBJECTIVE: The aim of this study was to explore critically ill patients' experience with the principle of informed consent in a clinical trial and their ability to give valid informed consent. DESIGN: 11 stroke patients who had been informed about thrombolytic treatment and had been through the process of deciding whether or not to participate in a thrombolysis trial went through repeated qualitative semistructured interviews. RESULTS: None of the patients had any clear understanding of the purpose of the trial. Neither did they understand the principles of randomisation and voluntariness. Reasons for giving or not giving consent were trust, conceptions of benefits and risks and altruism. Several patients found it immoral to involve patients in the consent procedure and argued that this was the doctors' responsibility. Others argued that it is a duty to question patients and perceived it as a sign of being treated with respect and dignity. A majority of the patients found the consent process vague and ambiguous. CONCLUSIONS: The results indicate that the principle of informed consent from critically ill patients cannot be seen as a contract between equal and autonomous parties. Further studies are needed to explore critically ill patients' experiences with the process of informed consent.